Medline Med-Soft Liners Recalled for Potential Fitting Difficulty
Medline Industries is recalling approximately 35,900 Med-Soft Liners due to a dimensional variation that could make them difficult to fit into the outer canister. No injuries have been reported.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for a medical device with a dimensional variation that could affect proper function, but with no reported illness or injury. The risk-of-harm nature of the defect and lack of reported adverse events places this at the maximum score for theoretical hazards.
Plain-English summary
Medline Industries, LP is recalling approximately 35,900 Med-Soft Liners with 6mm x 3m tubing due to a dimensional variation that could affect proper fitting into the outer canister. The affected lot numbers range from 670220505 to 670230424.
The dimensional variation may cause difficulty fitting the liner into the outer canister, which could affect proper device function. No injuries or adverse events have been reported to date.
The recalled liners were distributed worldwide, including throughout the United States and to Panama, Mexico, Canada, Qatar, El Salvador, Oman, Colombia, and Singapore. Customers should discontinue use of the recalled product and contact Medline Industries for replacement or return instructions.
The recalled product
- Product
- 1,5L MED-SOFT LINER W/ 6MMX3M TUB. & ADULT VC, REF OR53929
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device
- Hazard
- fitting-difficulty
- device-defect
- dimensional-variation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (15)
- UDI/DI 40888277422286 (package)
- 0888277DC265NSKX (unit)
- Lot Numbers: 670220505
- 670220609
- 670220621
- 670220720
- 670220804
- 670220926
- 670220928
- 670221024
- 670221115
- 670221227
- 670230109
- 670230210
- 670230424
Distribution
Distributed nationwide across the United States.
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